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Lenacapavir Injection
Lenacapavir is a first-in-class HIV capsid inhibitor that prevents the uncoating of HIV viral particles, blocking early steps of viral replication.
Lenacapavir is a first-in-class HIV capsid inhibitor that prevents the uncoating of HIV viral particles, blocking early steps of viral replication. Used for HIV-1 infection in treatment-experienced adults with multidrug-resistant virus.
At a glance
| Generic name | Lenacapavir Injection |
|---|---|
| Also known as | GS-6207, Yeztugo®, Sunlenca®, YEZTUGO® |
| Sponsor | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida |
| Drug class | HIV capsid inhibitor |
| Target | HIV capsid protein |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Lenacapavir binds to the HIV capsid protein and stabilizes the viral capsid structure, preventing the release of viral RNA and reverse transcriptase into the host cell cytoplasm. This novel mechanism of action targets a distinct step in the HIV replication cycle compared to traditional antiretrovirals, potentially offering activity against drug-resistant strains and a long-acting profile suitable for infrequent dosing.
Approved indications
- HIV-1 infection in treatment-experienced adults with multidrug-resistant virus
Common side effects
- Injection site reactions
- Nausea
- Diarrhea
- Headache
Key clinical trials
- Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy (PHASE1)
- ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention (NA)
- Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
- Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance (PHASE2, PHASE3)
- Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP) (PHASE3)
- HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots
- Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103) (PHASE2)
- ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |